FDA product code BYT: Ventilator, External Body, Negative Pressure, Adult (Cuirass)
BYT is the FDA product code for ventilator, external body, negative pressure, adult (cuirass). It is a Class II device, regulated under 21 CFR 868.5935 and reviewed by the Anesthesiology panel. FDA has cleared 21 510(k) submissions under BYT, from 15 different applicants. The average 510(k) review took 97 days (median 81).
Classification
| Field | Value |
|---|---|
| Device name | Ventilator, External Body, Negative Pressure, Adult (Cuirass) |
| Device class | Class II |
| Regulation | 21 CFR 868.5935 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every BYT clearance
Top BYT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Lifecare Services, Inc. | 3 | 1991-06-03 |
| J. H. Emerson Co. | 3 | 1990-11-19 |
| Respironics, Inc. | 2 | 1993-07-21 |
| Progressive Productions , Ltd. | 2 | 1990-07-19 |
| Medivent Limited | 1 | 2008-10-08 |
10 more applicants have BYT clearances. See the full list in Caduvo.
Most recent BYT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K082657 | Medivent Limited | RTX RESPIRATOR | 2008-10-08 | 26 |
| K072290 | Dima Italia Srl | PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS | 2008-05-29 | 287 |
| K924341 | Respironics, Inc. | HAYEK OSCILLATOR(TM) | 1993-07-21 | 328 |
| K910947 | Lifecare Services, Inc. | NEV-10 NEGATIVE PRESSURE VENTILATOR | 1991-06-03 | 89 |
| K905530 | Puritan Bennett Corp. | PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEM | 1991-03-01 | 81 |
Recalls for BYT devices
openFDA lists no recalls for product code BYT.
Frequently asked questions
What is FDA product code BYT?
BYT is the FDA product code for ventilator, external body, negative pressure, adult (cuirass). It is a Class II device, regulated under 21 CFR 868.5935 and reviewed by the Anesthesiology panel.
What device class is BYT?
Class II, regulation 21 CFR 868.5935. Typical premarket route: 510(k).
How long does a 510(k) take for product code BYT?
Across 21 cleared submissions the average was 97 days from receipt to decision (median 81).
Which companies have the most BYT clearances?
Lifecare Services, Inc. (3); J. H. Emerson Co. (3); Respironics, Inc. (2); Progressive Productions , Ltd. (2); Medivent Limited (1).
Next steps
- Run an FDA pathway report with predicate devices for product code BYT
- Run a recall and safety report across every BYT manufacturer
- Watch product code BYT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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